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Data is trickling in on a new COVID-19 strain nicknamed “pirola,” giving researchers a wider picture of what the variant could mean for the U.S. and the world. Van Kerkhove said that the global COVID-19 variant picture is complex, and that while BA.2.86 is spreading, it is not currently outcompeting other strains. “It is quite a complex picture globally in terms of how these variants behave because different variants circulate in different countries at different times.”Will Vaccines Work on Pirola? Moderna and Pfizer have announced that early data indicates that their updated vaccines do produce an immune response against BA.2.86. "These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant.
Persons: “ pirola, ” Mandy Cohen, Maria Van Kerkhove, ” Benjamin Murrell, Ashish Jha, pirola, Van Kerkhove, it’s, , , Stephen Hoge Organizations: U.S, CDC, Centers for Disease Control, World Health Organization, WHO, White, Moderna, Pfizer, EG Locations: United States, Denmark, Sweden, Portugal, Israel, Canada, South Africa
FDA Approval of New COVID Boosters Could Come by Friday
  + stars: | 2023-09-07 | by ( Sept. | At A.M. | ) www.usnews.com   time to read: +2 min
Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. This time, the FDA may grant full approval for the boosters rather than emergency use authorization, according to NBC News sources. If the FDA doesn’t approve the boosters on Friday, it could do so early next week. While protection wanes over time, about 97% of adults have some level of protective immunity from past COVID infections and vaccinations. The Biden administration has announced a “bridge” program to offer uninsured people access to free boosters through 2024.
Persons: Cara Murez HealthDay, Mandy Cohen, Jennifer Kates, Biden, Kates Organizations: U.S . Food, Drug Administration, NBC News, U.S . Centers for Disease Control, Prevention, Pfizer, Moderna, NBC, Global Health, HIV
FLORHAM PARK, N.J. (AP) — Aaron Rodgers crossed an item off his sports bucket list — and then made a statement with a more visible crossout. To mark the occasion, Rodgers posted a picture on a since-expired Instagram story of No. Political Cartoons View All 1148 Images“Well, I’m a big fan of Novak and I got to see him in person,” Rodgers said. Djokovic plays unseeded Ben Shelton in one men's semifinal Friday, while No. Rodgers and the Jets open their season on Monday night at home against the Buffalo Bills.
Persons: — Aaron Rodgers, Rodgers, Novak Djokovic, , Djokovic, Novak, ” Rodgers, COVID, Ben Shelton, Carlos Alcaraz, Daniil Medvedev, ___ Organizations: New York Jets, U.S, Green Bay Packers, COVID, NFL, FDA, Jets, Buffalo Bills Locations: FLORHAM, N.J, New York, New Jersey
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Persons: Dow Jones, 86549e1b
Moderna 's new Covid vaccine produced a strong immune response against BA.2.86, a highly mutated omicron variant that health officials are watching closely, according to clinical trial data the biotech company released Wednesday. The updated shot produced an 8.7-fold increase in protective antibodies against BA.2.86, which has been detected in small numbers nationwide. Moderna is the first out of the companies producing updated Covid jabs to release data on how its shot fares against BA.2.86. Last month, Moderna also released clinical trial data suggesting that its new shot provides protection against the now-dominant EG.5, or "Eris," variant and another rapidly spreading strain called FL.1.5.1. New vaccines are set to arrive as Eris and other Covid variants fuel a rise in cases and hospitalizations across the country.
Persons: Stephen Hoge, Covid hospitalizations Organizations: Disease Control, Moderna, Pfizer, Novavax, U.S . Food, Drug Administration, EG, CDC Locations: U.S
"These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. "Moderna will continue to rapidly assess global public health threats and is committed to leveraging our mRNA platform against COVID-19." The company’s announcement comes as the Biden administration prepares to authorize the updated shots from Moderna, Pfizer and Novavax as soon as next week. While the shots target XBB.1.5, which was responsible for about 3% of new infections in recent weeks, researchers are optimistic that it will hold up against other circulating variants. “With governments accelerating the timing of COVID-19 vaccination campaigns due to the potential risk of BA.2.86, Moderna has shared this data with regulators and is ready to supply its updated COVID-19 vaccine pending regulatory approval,” the company wrote in a press release.
Persons: “ pirola, Stephen Hoge, Ashish Jha, ” Pirola, Biden Organizations: Moderna, Wednesday, EG, COVID, White, Centers for Disease Control, Pfizer, Novavax Locations: U.S, Moderna
Moderna said its shot generated an 8.7-fold increase in neutralizing antibodies against BA.2.86 compared with an untreated natural antibody response in clinical trials in humans. Pfizer said its updated vaccine with partner BioNTech (22UAy.DE) elicited a strong antibody response against BA.2.86 in a preclinical study in mice. Moderna, Pfizer/BioNTech and relative newcomer to the COVID vaccine market Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant, the dominant variant through most of 2023. Moderna shares were down 1.6% and Pfizer shares were off nearly 3% in afternoon trading. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the target of the updated shots.
Persons: Moderna, Jacqueline Miller, BioNTech, Cowen, Tyler Van Buren, Dado Ruvic, Patrick Wingrove, Michael Erman, Bill Berkrot Organizations: Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, Moderna, REUTERS, CDC, Omicron, U.S . Food, Drug Administration, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York, New Jersey
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna: Updated Covid vaccine is effective against newer variantCNBC's Angelica Peebles reports on the latest news from Moderna.
Persons: Angelica Peebles Organizations: Moderna
[1/2] A vial and sryinge are seen in front of a displayed Moderna logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 6 (Reuters) - Moderna (MRNA.O) on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly-mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots. Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer review publication. European regulators have since backed the Pfizer/BioNTech shot, with Britain's Medicines and Healthcare products Regulatory Agency approving the vaccine on Tuesday, but have yet to make any announcements on Moderna’s updated vaccine.
Persons: Dado Ruvic, Jacqueline Miller, Moderna, COVID, BioNTech, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, CDC, Omicron, U.S . Food, Drug Administration, Pfizer, Moderna, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: The Massachusetts, Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York
The late summer Covid spike comes after a quiet year in which hospitalizations and deaths declined week after week since January. "We're living in a bit of a fantasy world where we're pretending Covid is not relevant," Birx told ABC in a podcast interview last week. Birx said those vaccines should have been released weeks ago to combat the predictable summer wave, adding the U.S. should already be developing new shots for January to target the emerging BA.2.86 variant. The updated shots should be effective at reducing severe disease and hospitalization from the variant, according to the agency. The first lady last caught Covid in August 2022 and the president tested positive in July of last year.
Persons: Shannon Stapleton, Reuters Covid, Deborah Birx, Trump, Covid, Birx, we're, Novavax, Moderna, Karine Jean, Pierre, Biden, Anthony Fauci, Fauci, It's, Still, Jill Biden, Joe Biden Organizations: Intensive Care Unit, Western Reserve Hospital, Reuters, hospitalizations, Centers for Disease Control, White, ABC, Pfizer, Moderna, CDC, U.S, BBC, National Institute of Allergy, White House Locations: Cuyahoga Falls , Ohio, U.S, ., Arkansas , Colorado , Indiana , Kansas , Minnesota , Oklahoma , Tennessee , Utah, Wyoming, China, Kentucky, Texas, India
An uptick in Covid cases and hospitalizations in the U.S., and the emergence of new variants of the virus, are prompting questions about whether Americans should start masking up again. One thing's for sure: People infected with Covid should wear masks around others to prevent the spread of the virus. That includes your personal risk level, Covid rates in your region and who you might make contact with, public health experts said. Newer Covid variants like the now-dominant EG.5, or "Eris," and a handful of XBB strains have fueled the rise. New Covid shots from Pfizer , Moderna and Novavax are slated to roll out in mid-September, and will likely provide robust protection against those variants.
Persons: Michael Nason, Donna Nason, Andrew Pekosz, Francesca Torriani, Pavitra, Axios Organizations: Centers for Disease Control, Johns Hopkins Bloomberg School of Public Health, CNBC, CDC, U.S, Pfizer, Moderna, University of California, University of Washington School of Medicine Locations: Bakersfield, Los Angeles , CA, California, U.S, Covid, San Diego
Ohio Governor Mike DeWine, right, shakes hands with Judge Thomas Rose of the U.S. District Court Southern District of Ohio after taking his oath of office, Monday, Jan. 14, 2019, in Cedarville, Ohio. A federal judge on Friday withdrew from a case that could block Medicare from negotiating over drug prices, just hours after a watchdog group revealed his ownership of stock in two pharmaceutical companies that would be directly impacted by the new program. He also owns Moderna stock worth between $15,000 and $50,000, the filing shows. The suit asked the court to rule that for Medicare to negotiate drug prices would be unconstitutional. Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the drugmaker lobby PhRMA have all filed complaints in different districts courts.
Persons: Mike DeWine, Judge Thomas Rose, Judge Thomas M, Rose, Biden, George W, Bush, Johnson, Boehringer Ingelheim, Robert Davis, Davis Organizations: U.S, District Court Southern District of Ohio, Southern, Southern District of Ohio, Johnson, AstraZeneca, Republican, Moderna, U.S . Chamber of Commerce, Department of Health, Human Services, Centers, Medicare, Merck, Bristol Myers Squibb, Court, Circuit Court Locations: Cedarville , Ohio, Southern District
Coronavirus is on the rise in the U.S., prompting questions about when Americans can roll up their sleeves for the next COVID-19 vaccine. The updated shots target XBB.1.5, which was responsible for less than 5% of new coronavirus infections in recent weeks. But all the strains circulating are still descendants of omicron, so experts believe the shots will still protect against severe COVID-19 from the variants. Historically, vaccine uptake decreases each time a new coronavirus shot is offered. Just 17% of Americans as of May rolled up their sleeves for the latest round of shots offered.
Persons: it’s, Biden, ” Mandy Cohen, Novavax, – Cohen, ” Cohen, Cohen, Organizations: Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, FDA, EG Locations: U.S, COVID, Moderna
A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. The sources declined to be identified because the information is confidential and cautioned a deal could still collapse at the last minute. Spokespeople for Catalent and Elliott declined to comment. In the past when Elliott has pushed for sales of pieces or the entire target company, including at eBay and Switch Inc., and then won board representation, significant ownership changes have followed. Novo Nordisk's weight-loss drug Wegovy is filled by Catalent’s Brussels factory and last week Reuters reported that Catalent’s plant in Bloomington, Indiana will begin filling Wegovy injection pens for Novo.
Persons: Yves Herman Acquire, Elliott, Catalent, Elliott isn't, Keith Meister's, Scott Ferguson's, Mauricio Gutierrez, Svea Herbst, Bayliss, Maggie Fick, Shri Navaratnam Organizations: REUTERS, Catalent, Elliott Investment Management, AstraZeneca, Johnson, Moderna, eBay, Inc, Deutsche Bank, Management, Capital Management, Reuters, NRG, Svea, Thomson Locations: Brussels, Belgium, U.S, Bloomington , Indiana, Novo, Boston, London
A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. Spokespeople for Catalent and Elliott declined to comment. The U.S.-based contract drugmaker is also Danish company Novo Nordisk's (NOVOb.CO) main manufacturing partner for its popular weight-loss drug Wegovy. The volatility at Catalent could increase scrutiny on the relationship between Novo and its partner. Reuters reported last week that a second Catalent factory will begin filling Wegovy injection pens for Novo as part of an expanded supply agreement.
Persons: Yves Herman Acquire, Elliott, drugmaker, Markus Manns, Catalent, Elliott isn't, Keith Meister's, Scott Ferguson's, Mauricio Gutierrez, Svea Herbst, Bayliss, Maggie Fick, Amanda Cooper, Shri Navaratnam, Bernadette Baum, Catherine Evans Organizations: REUTERS, Elliott Investment Management, Catalent, Novo, Reuters, Union Investment, AstraZeneca, Johnson, Moderna, eBay, Inc, Deutsche Bank, Management, Capital Management, NRG, Svea, Thomson Locations: Brussels, Belgium, U.S, Danish, Novo, United States, Germany, Boston, London
CNN —Covid-19 vaccines that have been tweaked to teach the body how to fend off the current crop of circulating variants are now expected to land in drugstores and clinics in mid-September, senior administration officials say. The US Food and Drug Administration is expected to give its nod to the updated vaccines in a few weeks. Officials said ACIP will meet quickly after the FDA decision in order to expedite the regulatory steps and get the vaccines to market. The advisory group is scheduled to meet to discuss Covid-19 vaccines on September 12, meaning the vaccines could become available soon after. The details of the pharmacy program are still being worked out, and there may be a slight lag in getting free vaccines at some stores.
Persons: CNN —, ACIP, Mandy Cohen, , Dr, Sanjay Gupta, Cohen, There’s Organizations: CNN, US Food and Drug Administration, US Centers for Disease Control, Officials, CDC, Covid, Pfizer, Moderna, FDA, EG, Affordable, CVS, Walgreens, Walmart, CNN Health Locations: drugstores, Covid
Amanda Jaffe, 69, went to her local pharmacy at the Safeway in Helena, Mont., to get the R.S.V. Upon hearing the price (over $300), Ms. Jaffe thought “that’s ridiculous” and left without getting it. Several common vaccines, including those for the flu and Covid-19, are included under Medicare Part B, which provides medical coverage. vaccines, as well as a few others, including the vaccine for shingles, are covered under Medicare Part D, which pays for prescription drugs. As a result, Medicare enrollees without a Part D plan — roughly 16 million people — may have to pay for the R.S.V.
Persons: Amanda Jaffe, , ” Ms, Jaffe, , Richard Hughes IV, Epstein Becker Green Organizations: Safeway, Medicare, Moderna, Centers, Medicaid Services, New York Times Locations: Helena, Mont
The Centers for Disease Control and Prevention expects updated Covid vaccines from Pfizer , Moderna and Novavax to be available to the public in mid-September, an agency official told reporters Thursday. CDC Director Mandy Cohen had previously provided a later timeline, telling NPR that the vaccines could be available by the "early October time frame." Those shots still need approvals from the Food and Drug Administration and the CDC, which will set eligibility guidelines for the jabs. Officials from the CDC and FDA said the agencies will encourage Americans to receive an updated Covid shot and other key vaccines ahead of the fall, when respiratory viruses typically begin to spread more widely. "Our goal, our imperative, our task is to make sure we're using those tools," the CDC official said.
Persons: Mandy Cohen Organizations: Disease Control, Pfizer, Moderna, Federal, NPR, Food and Drug Administration, CDC, FDA
Mutual fund managers have been able to generate alpha outside of Big Tech this year, with some stocks contributing sizable gains, according to Goldman Sachs. Goldman found the large-cap core have struggled this year due to their underweight in the largest tech stocks, which have led the market rally. However, mutual fund managers were able to find winners elsewhere, Goldman said. "An improving stock picking environment has helped mutual fund PMs generate alpha elsewhere in their portfolios," Goldman strategists said in a note. Top gainers in mutual fund portfolios also included energy stocks Chevron , Exxon Mobil and NextEra Energy.
Persons: Goldman Sachs, Goldman, Russell, — CNBC's Michael Bloom Organizations: Big Tech, Alpha, Pfizer, Johnson, Moderna, Chevron, Exxon Mobil, NextEra Energy
CDC said it was too soon to know whether this might cause more severe illness compared with previous variants. But due to the high number of mutations detected in this lineage, there were concerns about its impact on immunity from vaccines and previous infections, the agency said. Scientists are keeping an eye on the BA.2.86 lineage because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant. The agency had earlier this month said it was tracking the highly mutated BA.2.86 lineage, which has been detected in the United States, Denmark and Israel. CDC said on Wednesday the current increase in hospitalizations in the United States is not likely driven by the BA.2.86 lineage.
Persons: Pratik Jain, Shilpi Majumdar Organizations: Science, Trinity College, Reuters, U.S . Centers for Disease Control, Prevention, CDC, Thomson Locations: Dublin, Wuhan, United States, Denmark, Israel, hospitalizations, Bengaluru
Shares of Novavax jumped more than 13% on Tuesday after the biotech company said its new Covid vaccine generated a broad immune response against the now-dominant Eris variant and another fast-spreading strain of the virus in small animal trials. But the trial results suggest that the shot may still be effective against newer Covid variants gaining a greater foothold in the U.S. That includes Eris and XBB.1.16.6, both of which are also descendants of omicron. "We have a lot of confidence in our updated Covid vaccine and are working diligently with global regulatory bodies to ensure our protein-based vaccine is available this fall," Filip Dubovsky, Novavax's president of research and development, said in a release. The World Health Organization designated Eris a "variant of interest," meaning it will be monitored for mutations that could make it more severe. XBB.1.16.6 is also beginning to surge, accounting for 8% of all cases nationwide as of Saturday, the CDC said.
Persons: Novavax, Filip Dubovsky Organizations: Pfizer, Moderna, U.S . Food, Drug Administration, EG, Centers for Disease Control, World Health Organization, CDC Locations: U.S, hospitalizations
Covid vaccine makers' shares rose Monday as new variants of the virus emerge in the U.S. ahead of the rollout of updated shots this fall. Shares of BioNTech , which jointly develops Covid vaccines with Pfizer , popped nearly 7%. It's been a rocky few months for those stocks as sales of Covid shots and treatments plummet in the U.S.: Shares of all four companies are down more than 20% for the year. But Wall Street's enthusiasm for Covid vaccine makers is getting a fresh boost with the upcoming launch of brand-new shots this fall and the emergence of new variants of the virus. So far, there is no evidence that BA.2.86 spreads faster or causes more serious infections than previous versions.
Persons: Novavax, It's Organizations: Pfizer, EG, U.S . Health, CNBC, Moderna, Novavax, World Health Organization, U.S . Centers for Disease Control, Prevention Locations: U.S, Denmark, Israel
A 50-year-old and immunocompromised resident receives a second booster shot of the coronavirus disease (COVID-19) vaccine in Waterford, Michigan, U.S., April 8, 2022. On Thursday, Moderna (MRNA.O) said initial data showed its updated COVID-19 vaccine is effective against the "Eris" and "Fornax" subvariants in humans. Moderna and other COVID-19 vaccine makers Novavax (NVAX.O), Pfizer (PFE.N) and German partner BioNTech SE (22UAy.DE) have created versions of their shots aimed at the XBB.1.5 subvariant. Pending approval from health regulators in the United States and Europe, the companies expect the updated shots to be available in the coming weeks for the autumn vaccination season. "We will be encouraging all Americans to get those boosters in addition to flu shots and RSV shots," the official said, referring to the Respiratory Syncytial Virus.
Persons: Emily Elconin, Biden, BioNTech, Steve Holland, Lisa Shumaker Organizations: REUTERS, Rights, White, for Disease Control, Pfizer, Thomson Locations: Waterford , Michigan, U.S, Moderna, United States, Europe
Scientists are keeping an eye on the new lineage, named BA.2.86, because it has 36 mutations that distinguish it from the currently-dominant XBB.1.5 variant. So far there is no evidence that BA.2.86 spreads faster or causes more serious illness than previous versions. COVID infections and hospitalizations have been rising in the U.S., Europe and Asia, with more cases in recent months attributed to the EG.5 "Eris" subvariant, a descendant of the Omicron lineage that originally emerged in November 2021. But many countries have drastically reduced testing of patients and their efforts to analyze the genomes of the viruses causing new COVID cases. Updated COVID booster shots now being developed have been designed to target the Omicron subvariant XBB.1.5.
Persons: Emily Elconin, Wesley Long, Eric Topol, Topol, Long, Moderna, Eris, Deena Beasley, Nancy Lapid, David Gregorio Our Organizations: REUTERS, Moderna Inc, Pfizer, World Health Organization, U.S . Centers for Disease Control, CDC, EG, Omicron, Houston Methodist Hospital, Scripps Research, COVID, U.S, Pfizer Inc, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, United States, Israel, Denmark, La Jolla , California
New Covid vaccines from Pfizer , Moderna and Novavax will likely provide protection against the new "Eris" variant, now the dominant strain of the virus in the U.S. The drugmakers designed their updated vaccines to target the omicron subvariant XBB.1.5, which is slowly declining nationwide. Eris accounted for 17.3% of all cases in the U.S. as of earlier this month, according to the latest data from the CDC. The World Health Organization earlier this month designated Eris a "variant of interest," meaning it will be monitored for mutations that could potentially make it more severe. It's also not expected to cause a huge wave of Covid cases like other strains have in previous years.
Persons: Dr, Mark Mulligan, It's Organizations: Chicago Department of Public Health, Southwest Senior Center, Pfizer, Moderna, U.S, EG, NYU, Vaccine, CNBC, Food and Drug Administration, Disease Control, CDC, World Health Organization Locations: Covid, Chicago , Illinois, Novavax, U.S
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